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Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With Myelofibrosis

This study is currently recruiting participants.
Verified March 2013 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01014546
First received: November 16, 2009
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

This study determine the highest safe dose of arsenic trioxide with or without ascorbic acid and if the investigational drug arsenic trioxide along with ascorbic acid (vitamin C) is effective against JAK2 positive myelofibrosis.


Condition Intervention Phase
Primary Myelofibrosis
 Drug: Dose Escalating Arsenic Trioxide plus ascorbic Acid
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With JAK2-Positive Myelofibrosis

Resource links provided by NLM:

MedlinePlus related topics: Arsenic Vitamin C
U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • To determine the safety and maximum tolerated dose of oral arsenic trioxide with or without ascorbic acid is subjects with JAK2-positive myelofibrosis [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate the incidence, severity and attribution of treatment-emergent adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arsenic Trioxide & Ascorbic Acid
Arsenic Trioxide dose 0.15mg/kg to 0.55mg/kg with the addition of ascorbic acid (1,000 mg total dose)
 Drug: Dose Escalating Arsenic Trioxide plus ascorbic Acid
Dose Escalating Arsenic Trioxide starting at 0.15mg/kg plus 1000 mg dose of ascorbic acid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary myelofibrosis, essential thrombocythemia related myelofibrosis or polycythemia vera related myelofibrosis requiring therapy including previously treated and relapsed or refractory or newly diagnosed or with symptomatic splenomegaly or if newly diagnosed, with intermediate or high risk or with symptomatic splenomegaly
  • Detectable JAK2 V617F mutation
  • Signed Informed Consent: Patients must have signed consents for both the arsenic trioxide with ascorbic acid protocol and for the Hematologic Malignancy Procurement protocol to be eligible to participate.
  • Must have been off any experimental PMF-directed therapy for 4 weeks prior to entering study and have recovered from the toxic effects of that therapy Treatment with hydroxyurea and erythropoetin are permitted until study initiation.
  • Serum bilirubin levels <2 X Upper Limits of Normal
  • Serum SGPT and ALT levels <2 X Upper Limits of Normal
  • Serum creatinine levels <1.5 X Upper Limits of Normal
  • Negative pregnancy Test
  • At least 18 years old

Exclusion Criteria:

  • Nursing and pregnant females
  • NYHA Grade II or greater congestive heart failure
  • Unstable angina
  • QTc >450 in the presence of potassium >4 mEq/L and magnesium >1.5mEq/L
  • ECOG > 2
  • Major surgical procedure within 28 days of entering the study
  • Biopsy or minor surgical procedure within 7 days prior to study enrollment
  • Known hypersensitivity to any compound of arsenic trioxide
  • Ongoing serious, Non-healing wound, ulcer or bone fracture
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014546

Contacts
Contact: AskRPCI 1-877-275-7724 AskRPCI@roswellpark.org

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Cephalon
Investigators
Principal Investigator: Meir Wetzler, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01014546     History of Changes
Other Study ID Numbers: I 154609
Study First Received: November 16, 2009
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
JAK2 positive

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Ascorbic Acid
Arsenic trioxide
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013